The injection needle should be filled (primed) with approximately 1 mL of reconstituted BOTOX prior to the start of injections (depending on the needle length) to remove any air.
Histology slides demonstrate deposition of new collagen around CaHA microspheres over an extended period of time. Collagen fibers stain red, while other tissue elements appear more yellow.
In 1997, the original formulation was changed to reduce the protein load per dose, and since then treatment failure rates have dropped; however, experts estimate that 0.3 to seis% of people are still at risk of antibody development. The risk is greatest when dosages of more than 200 units per session are used, and reinjection occurs within one month. Experts are unsure if neutralizing antibodies resolve over time or if injections of botulinum toxin type B products are useful in patients with neutralizing antibodies to type A.
It is not known if onabotulinumtoxinA passes into breast milk. Talk to your healthcare provider about the best way to feed your baby.
There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. Pelo cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient’s response to previous treatment, or adverse event history with BOTOX.
The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of BOTOX and muscles to be injected.
The potency Units of BOTOX (onabotulinumtoxinA) for injection are specific to the liftera preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses [see Warnings and Precautions (5.1)].
Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE® may cause nodules, bumps or lumps in the back of the hand and can last up to 1 year.
Use of BOTOX for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk. 5.13 Urinary Retention in Adults Treated for Bladder Dysfunction
Speak to your doctor about how drug interactions should be managed. Botox interacts with just over 110 different medications. Common medications that may interact with Botox include:
The initial dose for a patient without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response. Limiting the total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia.
Overcorrections lasting over six months have been rare. About one half of patients will require subsequent doses because of inadequate paralytic response of the muscle to the initial dose, or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment.